South Asians, the second fastest growing ethnic group in the Unites States (U.S.), have an elevated risk of early and aggressive cardiovascular disease (CVD) compared to non-Hispanic Whites and other Asian subgroups. Recent mortality statistics show that South Asians have a higher heart disease mortality rate than these other racial/ethnic groups, suggesting an urgent need for targeted public health efforts. Although intensive diet and physical activity counseling interventions are recommended for individuals with CVD risk factors, our prior research identified that existing lifestyle interventions are not reaching South Asians because these interventions did not address the social and cultural determinants of cardiovascular health. Using community-based participatory research, we developed and pilot-tested the South Asian Healthy Lifestyle Intervention (SAHELI), a theoretically-driven lifestyle intervention that integrates evidence-based behavior change techniques with the community’s sociocultural context, needs, and beliefs. The intervention includes weekly group classes, experiential activities, and motivational interviewing to increase the components of self-regulation that have been shown to be most effective for eliciting diet and physical activity changes. The pilot study (n=63) established feasibility and acceptability of the SAHELI intervention, had a 100% retention rate at 6 months, and showed significant improvements in weight and hemoglobin A1c among intervention participants compared to a control group. The goal of the proposed study is to conduct a randomized controlled trial to test the efficacy of the SAHELI intervention in a larger, more generalizable at-risk South Asian population and to collect information on the intervention’s potential for implementation in real-world settings. Our Primary Aims are to: 1) Determine whether participation in the SAHELI intervention is associated with significantly greater improvements in clinical risk factors associated with CVD (primary outcomes of systolic and diastolic blood pressure, cholesterol, glycated hemoglobin, and weight) relative to a comparison group that receives print education materials on healthy lifestyle; and 2) Conduct a multi-stakeholder implementation evaluation to evaluate the SAHELI intervention and community-based participatory research process. We hypothesize that the SAHELI intervention will result in significantly greater improvements in clinical risk factors than print education materials at 12 months. In Secondary Aims, we will determine SAHELI’s effect on behavioral and psychosocial outcomes, and examine mediators of intervention effect. The proposed study expands on our prior research by using an effectiveness and preliminary implementation (type 1 hybrid) design, which tests the effects of a clinical intervention on relevant outcomes while observing and gathering information on initial implementation. Given the lack of evidence on effective lifestyle interventions for South Asians at-risk for CVD, the proposed research is of scientific and public health import.
|Effective start/end date||6/1/17 → 5/31/22|
- National Heart, Lung, and Blood Institute (5R01HL132978-03)